1. Provide QA review and release of raw material, in-process product, and finished goods documentation to verify compliance to SOPs and regulatory requirements.
2. Work closely with the Manufacturing department to provide on-going Quality support.
3. Write, revise, and review SOPs.
4. QA on the floor activities (e.g. verifications, inspections, etc.)
5. Ensure quality and consistency in documentation and adherence to SOPs.
6. Maintain expertise in quality systems (e.g. change control, critical system, etc) and ability to identify and initiate non-conformance events.
7. Assist with continuous improvement initiatives / projects.
8. Participate in internal or external audits and support audit observations as needed.
9. Ensure training requirements are met and records are up to date.
10. Maintain and update departmental metrics and reporting.
11. Represent QA at cross-functional meetings, providing QA input and level appropriate decision making.
12. Provide training to group and departments when needed
13. Work with department supervisor to identify and drive improvement opportunities.
14. Ensure the timely release of products, intermediates and clinical/IND lots, according to schedule.
15. Work closely with Manufacturing, Quality, and Engineering to ensure adequacy and appropriateness of release requirements for rooms and equipment.
16. Responsible for change control activities/documentation assigned to Quality Ops – batch review team.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to collaborate, encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA and EU Regulations and Application of Good Manufacturing Practices.
Education and/or Experience:
Include the education and experience that is necessary to perform the job satisfactorily.
BS in biological science or equivalent. 3-5 years exp. in Quality.
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